Protecting Cancer Care: Improving Transparency and Patient Access

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Protecting Cancer Care: Improving Transparency and Patient Access
Protecting Cancer Care:
                      Improving Transparency
                      and Patient Access
                      A White Paper from the Oncology Therapy Access Physicians Working Group

                       H    istorically, cancer care
                            has been protected
                       from many of the insurance
                                                          to instantly solve all of these problems,
                                                          improvements in the areas of patient
                                                          access and transparency are essential,
                       issues that have beset other       and thus these are good places to begin.
                       diseases. The life threatening
                       nature of cancer was
                                                          IMPROVING PATIENT ACCESS TO
                       recognized by physicians,
                                                          CANCER TREATMENTS
                       patients, and payers alike,
                                                          The cost of cancer care in the United
                       and the barriers to obtaining
                                                          States exceeds $125 billion annually and
                       payments from insurers
CONTENTS                                                  is expected to increase nearly 40% by
                       were minimal. Over the
                                                          2020.1 The escalating costs of treatment
1 Improving Patient    past decade, however, this
                                                          have been attributed to the aging
  Access to Cancer     situation has changed. Policies
                                                          population, increased diagnosis of cancer,
  Treatments           dictated by insurers have
                                                          and new state-of-the-art medications
2 Specialty Tiers      begun to erode the protection
                                                          targeted at specific molecules on cancer
                       that formerly characterized
3 Prior                                                   cells.1 Many of these new medications
                       coverage of cancer treatment.
  Authorization                                           dramatically improve the treatment
                       This trend is manifested by
                                                          of cancer and it is often argued that
4 Coverage Parity      reduced patient access to high
                                                          solutions to the cost issues must also
5 Improving            quality cancer care and a lack
                                                          preserve the development of innovative
  Transparency         of transparency regarding the
                                                          therapies.
  in Cancer Care       recommended treatments.
                                                          In response to the demographic and
6 Transparency of      As physicians, we are
                                                          economic trends in cancer care, insurers
  Clinical Pathways    committed to providing
                                                          have devised a number of strategies
                       the best care possible for
7 Conclusions                                             designed to mitigate their costs.
                       our patients. However, we
                                                          Unfortunately, many of these policies
                       face serious challenges in
                                                          limit patient access to treatments from
                       meeting this goal, including
                                                          which they could benefit. Three of the
                       the complex nature of cancer,
                                                          main policies that must be amended
                       involvement of multiple
                                                          in order for patients to access cancer
                       medical specialists, numerous
                                                          therapies are (1) specialty tiers/high co-
                       treatment options, a confusing
                                                          pays, (2) prior authorizations, and (3)
                       insurance system, and the
                                                          parity of coverage not only for infusion
                       inability of our patients to pay
                                                          and oral therapies, but also for site of
                       their sometimes outrageously
                                                          care. Each of these policies is discussed
                       high out-of-pocket expenses.
                                                          in the following sections.
                       Although it is not possible
              INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE                     OCTOBER 2014 1
of our patients cannot afford them—
    Patients Surviving At Least 5 Years
       After Being Diagnosed with                  or cannot do so without a significant
        Chronic Myeloid Leukemia                   financial hardship. For example, specialty
                                                   tier medications cost $40,500-95,000
100%
                                                   per patient per year4, and co-pays for
80%                                                drugs on the specialty tier often range
                                                   from 25% to
60%
                                                   33%.5 This means
                                                                         “I worry about the
40%                                                that patients
                                                                         middle class. They
                                                   who require a
20%                                                                      make too much
                                                   specialty tier drug
 0%                                                with an annual        money to qualify
       Before Imatinib            After Imatinib   cost of $60,000       for pharmaceutical
        (1990-1992)                  (Today)                             company-sponsored
                                                   would need to
       Sources: American Cancer Society, 20122
                                                   pay $15,000           assistance programs,
               and Druker et al, 20063
                                                   out of pocket         but cannot afford the
Specialty Tiers                                    per year for          cancer medications.
Insurance plans typically incorporate              their medication      One of my patients
several “tiers” that determine the level           alone (based          was a professional
of patient cost sharing or the amount of           on a typical          whose cancer was
medication cost that must be paid by               25% co-pay) in        not improving with
beneficiaries (i.e., co-pay). The lowest           addition to their
                                                                         treatment. I just
level of cost sharing, tier 1, usually             other co-pays
                                                                         couldn’t figure out why.
includes generic drugs. Tier 2, the next           and deductibles
                                                                         After we lost him, I
higher co-pay level, typically includes            for office visits,
preferred name-brand drugs, and tier                                     found out that he had
                                                   surgery, and
3 includes non-preferred, name-brand               hospital care. This
                                                                         not taken his high-cost
drugs. Tier 4, or the “specialty tier,”            is an exorbitant      medicine because he
includes the more expensive drugs such             amount of money       didn’t want to bankrupt
as those targeted toward specific types            for most people.      his family. It goes
of cancer.                                                               without saying that such
                                                   Further
                                                                         tragedies should not
            Typical Medication Tiers in            complicating this
             Healthcare Benefit Plans              scenario is the
                                                                         have to happen.”
 Tier 1        Generic drugs                       impact of cancer      -Dr. Nadim Nimeh, MD
                                                   on a person’s
 Tier 2        Preferred name brand drugs
                                                   ability to work.
 Tier 3        Non-preferred name brand drugs
                                                   Cancer and its
 Specialty     Higher cost medications,            treatment can
 Tier          including many cancer therapies
                                                   lead patients to
The problem with this scheme is that               quit or lose their
co-insurance costs for the specialty tier          jobs and hence
drugs are typically so high that many              their insurance,

 INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE                           OCTOBER 2014 2
which in turn can lead to insurmountable           Clearly, specialty tiers that require high
financial burdens, including bankruptcy.6          co-pays are unaffordable for most
To help minimize the financial burden,             patients. One potential solution is for
many patients do not take their                    insurers to raise their co-pays on lower-
medications as prescribed,7 which of               tier (i.e., less expensive) drugs to offset
course reduces or even negates the                 the costs of specialty tier medications.
effectiveness of treatment.                        Other solutions are also possible, and
                                                   it is imperative that stakeholders work
        Financial Distress Associated              together to identify policies that
           With Cancer Treatment
                                                   preserve the needs of insurers while
• Cancer patients are 2.65 times more likely       increasing patient access to specialty tier
  to go bankrupt than people without
                                                   cancer therapies.
  cancer.6
• A random sample of people who filed for          Prior Authorization
  bankruptcy in the US found that >60%
  filed because of medical bills—even though       Another policy that limits patient
  ¾ had insurance at the time of their illness.8   access to cancer treatments is prior
• In a study of 300 insured adults with            authorization. Prior authorization is the
  cancer:7
                                                   approval of a therapy by insurers before
   - 16% reported high or overwhelming
     financial distress                            it is given to a patient. The concept of
   - 27% did not adhere to their medication        pre-approval is not, in itself, a problem.
     regimen                                       However, problems arise when insurers
   - 14% skipped doses to make the                 take a prolonged time to approve
     medication last longer
                                                   therapies, particularly when they are
   - 11% took less medication than pre-
     scribed to make medication last longer        urgently needed to help reduce cancer
   - 22% did not fill a prescription because       growth or, in the case of supportive care
     of cost                                       drugs such as hematopoietic growth
                                                   factors, reduce the risk of serious
Hundreds of advocacy groups have                   complications of treatment. Some states
alleged that the high patient costs for            have passed legislation that requires
specially tier medications discriminate            insurers to respond to prior authorization
against those with cancer, multiple                requests within 48 hours or the request is
sclerosis, AIDS, and other chronic                 automatically approved.10,11 Moreover, due
diseases—the ones who require specialty            to variation in the forms physicians must
tier medications.9 Under many insurance            fill out for pre-approval, the legislation
plans, these patients are required to              requires that all prior authorization
pay percentages rather than flat co-               requests be standardized, with electronic
pays and higher overall dollar amounts             submissions allowed. These steps greatly
for their medications than patients with           improve the prior authorization system
other diseases. This is true even for              and should be implemented by all states.
insurance plans sold through exchanges
                                                   Prior authorization policies could be
developed under the Affordable Care Act,
                                                   further improved with several additional
in which non-discrimination was a major
                                                   common sense amendments. First, if
provision.9
INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE                            OCTOBER 2014 3
insurers pre-authorize therapies, they       was to increase patient access by making
should pay for them. Pre-authorized          needed medications available to more
claims should not be up for re-review        patients.11 There is general agreement
after they have been approved and            that this program is very effective when
the patient has already received the         applied as intended.
therapy. Although this seems intuitive,
                                             If this program were misused by eligible
it is not uncommon for insurers to deny
                                             institutions, however, it could have an
pre-authorized claims after the fact.
                                             unforeseen consequence of contributing
Moreover, if the drug is being used in
                                             to the closure of local community cancer
line with its Prescribing Information as
                                             centers. These closures may prove
approved by the US Food and Drug
                                             problematic in rural areas where patients
Administration, physicians should be
                                             may have to drive many miles for care.
able to treat patients prior to receiving
                                             Commuting to the city is difficult for
pre-approval.
                                             patients with limited income and for
Coverage Parity                              seniors, who may have trouble navigating
Parity for Site of Service                   urban roadways and parking lots or
Coverage parity refers to comparable         must rely on family members or friends
insurance coverage for comparable            to drive them. Furthermore, seniors may
services and medicines. Several parity       feel more comfortable at local centers
issues are at the forefront of cancer        and may therefore be better able to
care today, one of the most notable of       explain their symptoms, which in turn
which involves the site of cancer care. In   will result in better care. Experts agree
the United States, cancer treatment is       that local cancer centers are in danger of
available at various locations, including    extinction, with a study by the American
community clinics, hospitals affiliated      Society of Clinical Oncology (ASCO)
with universities, and private hospital      finding that 63% of small oncology
outpatient centers.                          practices were likely to merge, sell, or
                                             close operations in the coming year.13
Although it seems logical for insurers
to provide comparable coverage for           Infused Versus Oral Medications
medicines and services at all of these       Another notable parity issue in cancer
locations, certain treatment sites tend      is the preference that insurers give to
to have a disproportionate number of         medications (i.e., chemotherapies) that
uninsured or underinsured patients—          must be injected or infused over those
often in populous inner city areas. In       taken orally in the form of pills. Oral
order to make it possible for physicians     agents have a number of advantages
and institutions to treat these patients,    over injection and infusion therapies,
federal programs such as 340B Drug           such as being more convenient—
Pricing Program were implemented.            swallowing a pill is easier than traveling
The 340B program mandates that               to a treatment center for a prolonged
drug manufacturers sell medicines to         intravenous infusion and minimizes
qualifying institutions at significantly     disruptions in work and everyday life.
reduced prices.12 The goal of this program   Moreover, many of the recently approved,
INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE                     OCTOBER 2014 4
state-of-the-art medications that target     or not covered by their insurance, and
molecules associated with cancer cells       the out-of-pocket expenses for which
are available only in oral formulations.     they are responsible. Insurance-related
However, traditional infusion therapies      costs are typically hidden in verbose
are preferred for some patients due          policies that are difficult for patients
to personal and cancer-specific              to understand, and cancer centers
considerations.                              studiously avoid publicizing the costs of
                                             their services and procedures. However,
In many states, insurers still differ in
                                             patients want to know these costs and
the extent to which they cover infusion
                                             to discuss them with their healthcare
therapies and oral therapies for the
                                             providers, as indicated by a recent survey
same types of cancer. For traditional
                                             of men with advanced prostate cancer.16
chemotherapy administered via infusion
into the vein, patients must typically
pay a set fee for the medication and its       “Reducing price variation
infusion.14 Annual out-of-pocket costs are     for the 108 million Americans
usually capped as part of the medical
                                               with employer sponsored
benefit of the patient’s insurance plan.
In contrast, oral agents to treat cancer       insurance could save the
are typically covered under patients’          nation as much as $36 billion
pharmacy benefit plan, which requires
                                               per year.”
them to pay a percentage of the drug’s
cost—which can run into the tens of            Thomson Reuters, 201217
thousands of dollars annually if the drug
is classified by the pharmacy benefit        In addition to the high costs of cancer
plan as “specialty tier.” Moreover, there    care, several other developments are
is often no out-of-pocket limit for          nudging the system toward greater
these medications.14                         transparency. These include patient
                                             access to electronic information and
The good news is that 33 states and
                                             studies showing that healthcare costs
the District of Columbia have now
                                             for the same procedure in the same
passed laws requiring insurers to
                                             geographic area can vary by more than
provide coverage parity for oral cancer
                                             100%. Indeed, it has been estimated
therapies.15 Extending these laws to
                                             that reducing price variation for insured
the remaining states is a priority for
                                             individuals could save the US $36
improving patient access to cancer care.
                                             billion annually.17
                                             To improve transparency, insurance plans
IMPROVING TRANSPARENCY IN                    should include clear formulary lists and
CANCER CARE                                  provider networks. They should include
Transparency of Costs, Coverage,             the tiers and co-pays with real-world
and Co-Pays                                  examples of amounts that patients
Cancer patients are frequently surprised     would need to pay for some of the
by the costs of care, the items covered      most common diseases. The costs of
INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE                     OCTOBER 2014 5
therapies, including diagnostics, imaging,
                                                  • Initially, payments should be increased
and medications, along with other fees,             for practices using pathways; increases
should be made apparent to patients.                should be large enough to cover the cost
                                                    and time of acquiring and implementing
Transparency of Clinical Pathways                   pathways.
Clinical pathways specify which                   • CMS should develop a certification
                                                    process for care pathways.
treatments patients should receive
                                                  • After certified pathways have been
and in which order. They are typically              developed, practices should be expected
developed by physicians working with                to use and adhere to them, and
                                                    payments should be reduced if pathways
insurers who consider both available                are not used.
evidence and cost; in this way, clinical          • Payers and providers should collaborate
pathways can help reduce costs and                  to evaluate the effectiveness of pathways
                                                    in improving patient outcomes and
even improve cancer care.18 Many clinical           controlling costs.
pathways are well designed and accepted
by physicians. Unfortunately, however,
some do not rely as heavily on evidence          Following the development of clinical
and are designed based on cost of care           cancer pathways, insurers typically
instead of professional consensus. The           offer financial incentives to physicians
American Society of Clinical Oncology            or physician practices for adhering to
has outlined guiding principles for the          them a certain percentage of the time.
development and use of cancer care               According to the US Oncology Network,
pathways, as listed in the following table.      this percentage is ideally about 80%—
                                                 meaning that about 80% of patients are
                                                 suitable for the pathways.20 This leaves
      ASCO Guiding Principles for the            room for flexibility 20% of the time to
     Development and Use of Oncology
             Care Pathways19                     accommodate patients with special
                                                 circumstances. For instance, if the clinical
• Pathways should be developed with the          pathway specifies a treatment that can
  input of oncologists.
                                                 cause severe skin reactions, patients with
• Pathways should describe all aspects of
  cancer care, not just anti-cancer treatment.   a history of such reactions may be better
• Pathways should give appropriate               suited to a different medication that
  consideration to costs of alternative          provides comparable benefits but with
  approaches to care.
                                                 less risk of skin reactions.
• Oncology practices should be able to use
  the same pathways with all payers.
                                                 Perhaps more disconcerting are the
• Efficient methods of using pathways and
  of documenting and auditing adherence          insurers who pay physicians for each
  to pathways should be developed.               patient they keep on their pathways. For
• 100% adherence to pathways is likely           example, WellPoint, the second largest
  impossible and undesirable; deviations
  should be used to advance knowledge
                                                 insurer in the US, pays oncologists $350
  about appropriate care.                        per patient per month to remain on one
• Standards for adherence to pathways            of their clinical pathways.21 In this case,
  should be established in advance based         there is a financial incentive for physicians
  on evidence and experience.
  				continued                                  to place each individual patient on a

INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE                           OCTOBER 2014 6
pathway. If physicians deviate from                              to rein in their own costs, insurers may
the pathway, which will certainly occur                          require exorbitant co-pays/co-insurance
in selected cases, they will still get                           for state-of-the-art medications,
reimbursed.22 However, the physician                             fail to respond to requests for prior
will not receive $350 per month for                              authorization in a timely manner, and,
those patients.                                                  unbeknownst to the patient, pay doctors
                                                                 to place them on a clinical pathway
Moreover, clinical pathways can be
                                                                 designed to utilize treatments that
different for each insurer, forcing
                                                                 combine efficacy with lower cost.
physicians into a “treatment by insurance”
routine where the treatment patients                             Part of the solution to the cost challenges
receive varies by which insurance they                           may lie in greater transparency across the
have.21 Many experts believe that it should                      entire healthcare system. When costs of
be the practice or hospital that develops                        procedures and medications are readily
the pathways and insurance companies                             accessible and insurance policies written
that agree to abide by them rather than                          in an approachable manner, patients will
the other way around.                                            engage in informed healthcare choices.
Regardless of which clinical pathway                             These issues are especially critical in
is followed, however, patients have                              cancer given the serious nature of the
a right to know what care is being                               disease. It is unfair for people who have
recommended for them and what they                               paid their insurance premiums and/
are scheduled to receive—that is, the                            or Medicare payroll taxes for decades
pathway and the financial incentives                             to be surprised by lack of adequate
must be transparent. Although many                               coverage when they need help paying
might decry the inability of patients to                         for a life-and-death illness. Policymakers
understand such information, there is                            and citizens must work to protect
clearly a trend toward greater patient                           patient access to cancer therapies by
engagement in cancer care and a call                             promoting transparency and rectifying
from the Institute of Medicine to provide                        patient unfriendly insurance practices
information that patients can understand.1                       such as specialty tiers, prolonged
                                                                 prior authorizations, and lack of equal
CONCLUSIONS
                                                                 coverage for comparable services
The cost of cancer care continues to rise,
                                                                 and treatments.
compromising our patients’ ability to
access needed therapies. In an attempt

                               ONCOLOGY WORKING GROUP MEMBERS
 Robert Miller, M.D.            Rachel Brem, M.D. Lucy Langer, M.D.                                David Charles, M.D.
  Alan Marks, M.D.              Emily Chan, M.D.  Nadim Nimeh, M.D.
                 Please note that the views expressed in this document do not necessarily reflect those of the
                               institutions with which the Working Group Members are affiliated.

                                  Join AfPA’s Oncology Therapy Access Physician Working Group
Established in 2014, the Oncology Therapy Access Physicians Working Group is a home for oncologists interested in health policy
issues relating to access to cancer therapies. Working Group members collaborate in development of educational resources such
as white papers, policy briefs and videos to be utilized in encouraging informed policymaking, while ensuring the physician’s
perspective is shared as policymakers consider how to balance access and costs. Physicians interested in joining the working group
or participating in an upcoming meeting should contact AfPA at www.AllianceforPatientAccess.org or call 202-499-4114.

INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE                                                       OCTOBER 2014 7
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    This white paper is authored by the members of the Oncology Therapy Access Physicians Working Group
                                and sponsored by the Institute for Patient Access.

                                                        I f PA
                                                   Institute    for Patient Access

                                             www.InstituteforPatientAccess.org
             The Institute for Patient Access • 2000 M Street NW Suite 850 • Washington, DC 20036
    The Oncology Therapy Access Physicians Working Group is a project of the Alliance for Patient Access.
     The working group is supported by educational donations from: Astellas Pharma US, Inc., Millennium
               Pharmaceuticals, Inc., Bristol-Myers Squibb and the Institute for Patient Access.

INSTITUTE FOR PATIENT ACCESS • PROTECTING CANCER CARE                                                            OCTOBER 2014 8
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