Patient Out-of-Pocket Expenses

For patients with chronic diseases like bleeding disorders out of pocket expenses for prescription drugs are a significant concern.  The average annual cost of clotting factor therapies for a person with severe hemophilia is roughly $300,000. Medical expenses for a person with severe hemophilia, the most common form of hemophilia, can be twice that. A person with an inhibitor (an immune response to replacement clotting factor) usually has expenses over a million dollars a year.

The treatment needs of a person with a bleeding disorder don’t typically vary during the year.  Patients need access to replacement clotting factor or other non-factor therapy year ‘round.  Even the “average” hemophilia patient incurs tens of thousands of dollars of expenses monthly due to the treatment.

NHF is a member of the SAIM Coalition, which advocates for state legislation to ease the burden of high prescription drug costs on patients.

“To help address the rising cost of healthcare and prescription drugs, many insurers are implementing plans that shift more of the cost to patients.  For example, these cost-sharing approaches include high deductibles that patients must meet before their healthcare or medications are fully covered and coinsurance, in which patients must pay a percentage of total costs rather than a set copay.  High deductibles and coinsurance are difficult to avoid when shopping for a health plan, as these cost-sharing techniques are a standard feature of plans available today.”

“Although cost-sharing approaches can be costly for any patient, plans with high deductibles and coinsurance are particularly burdensome for patients with chronic diseases who require specialized care and medication for months or years at a time.”

“These patients are likely to have to pay their full deductible every year, often within a relatively short timeframe. Even after they have met their deductible, they are required to pay a percentage of prescription drug costs, which are costly for the specialty tier medications used for many chronic diseases.”

“Coinsurance requirements also make it difficult to budget for their health expenses each year because they must pay a percentage of their overall healthcare costs rather than just a deductible and set copays.”

“The SAIM Coalition works to limit the burden of out-of-pocket by advocating for laws and regulations that require insurers to offer copay only cost-sharing insurance products in which the copays are proportionate to formulary tiers.”1


In 2020 New Jersey enacted a SAIM-supported bill, capping a five-year effort in that state.  However, patient-friendly legislation in Illinois and Ohio did not advance.



Copay Accumulator Adjustment Programs

In response to increases in health care costs, payers, especially self-insured plans, began shifting more of those costs to patients through higher deductibles, higher coinsurance, and placing specialty drugs on higher cost sharing tiers.  In response to these cost shifting trends, pharmaceutical manufacturers began to offer copay assistance programs for many life-saving specialty medications that lack generic equivalents.  Payers countered with copay accumulator adjustment programs (CAAPs).

Manufacturer copay assistance cards have positive benefits for patients (improves access, affordability, and compliance).  However, an increasing number of health insurance plans believe they drive up prescription drug costs by assisting beneficiaries in satisfying part or all their individual out of pocket (OOP) costs.

CAAPs target manufacturer copay assistance programs available for specialty drugs by no longer allowing expenses paid for with the assistance to count towards a member’s annual deductible or maximum out of pocket expense calculation (accumulator), believing that manufacturers use them to steer patients to higher cost drugs, rather than lower-cost generic equivalents.

Their contention is that if a patient has little to no personal share of the costs, they will have no incentive to consider generic alternatives, formulary, or preferred drugs and would likely not think twice about getting unnecessary tests, procedures, and labs.

CAAPs may actually result in higher costs to the payer when rolled out as a one-size-fits-all solution to high-cost medications.  This approach is short-sighted when applying the same ideology to life-saving specialty medications that have no generic alternatives.

CAAPs interfere with a vital lifeline for patients with chronic conditions needing specialty drugs that have no low-cost generic alternative.  They negate the benefits of copay assistance programs for those with a chronic/rare disease and reintroduce financial barriers to access.

Increasing patient cost sharing has a direct correlation with decreased adherence.  For those with rare diseases such as hemophilia, whose total cost of care exceeds the six-figure range annually, >90% of which is attributed to the drug cost, non-adherence will almost always produce unintended consequences (i.e., increased ER visits, joint bleeds/damage, missed workdays, etc.).  Collectively, this results in much higher costs to the payer than the perceived savings from this cost sharing shift.


CMS’ 2021 Notice of Benefit and Payment Parameters Rule allows health insurers to exclude manufacturer copay assistance from a patient’s annual out of pocket maximum.  NHF submitted comments to CMS opposing this change in policy.

Since 2019 five states and Puerto Rico have enacted either restrictions on the use of CAAPs or an outright ban.

NHF is a member of the All Copays Count coalition, a national alliance of patient advocacy organizations advocating for an end to the use of CAAPs.  In 2021, state coalitions, many operating under the All Copays Count umbrella, have succeeded in introducing CAAP legislation in more than twenty states.

Kentucky recently became the first state in 2021 to adopt restrictions on the use of CAAPs.  In several other states legislation has been passed by at least one legislative chamber.



Copay Assistance

For patients with complex, chronic conditions like hemophilia, finding the right specialty drug treatment can be a long and difficult journey.  A large percentage of patients with hemophilia rely on copay assistance programs to mitigate the cost sharing obstacles that prevent them from accessing their life saving treatments. This assistance may come from a manufacturer copay discount card or a nonprofit organization that offers financial assistance to patients.

Payers argue that copay assistance masks the true cost of prescription drugs and incentivizes patients to use higher cost brand name drugs rather than lower cost generics.  In addition to utilization of accumulator adjuster programs, payers have advocated for outright copay assistance bans in state legislatures.


In recent years legislation banning the use of third-party copay assistance has been introduced in some states, including New Hampshire and California.  NHF has assisted chapters when necessary to oppose such legislation.  In 2017 the New England Bleeding Disorders Advocacy Coalition successfully turned back an attempt to move a copay assistance ban bill in the New Hampshire state legislature.

Copay assistance bans remain a top priority for NHF’s state policy advocacy program.  The State Government Relations team works with chapters to monitor these bills and act where necessary.



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