Preamble

The Council of Medical Specialty Societies (CMSS), with 43 member societies representing 790,000 physician members in the US, is concerned that access to appropriate health care is being compromised by the inability of many patients and families to afford needed medications.

Below are principles that the Council of Medical Specialty Societies recommends to facilitate access by adults and children to needed medications.

Transparency

CMSS supports transparency to patients and prescribers in the pricing, cost, and comparative value of all pharmaceutical products, including transparency in insurance coverage policies for specialty, brand name and generic pharmaceuticals.

CMSS supports more transparency in formularies, including providing the estimated cost-sharing, co-payment and co-insurance amounts in plain language in a format that is readily accessible by consumers. CMSS believes that patients and physicians should have access to real-time cost information available at the point of prescribing to ensure that cost considerations are a meaningful part of shared decision making in health care.

CMSS supports transparency in rebates offered to physicians, practices, hospitals, health systems, payers and insurance companies offered by manufacturers, distributors and pharmacy benefit managers (PBMs), as well as rebates to PBMs from manufacturers. CMSS also calls for more transparency in the negotiation processes of PBMs.

Formularies and Tiers

CMSS recommends that payers which use tiered or restrictive formularies ensure that patient cost-sharing for specialty drugs is not set at a level that imposes a substantial economic barrier to enrollees obtaining needed medications, especially for enrollees with lower incomes. CMSS believes cost sharing for patients should not prevent patients from accessing needed prescriptions, thus jeopardizing the recommended course of treatment.

CMSS believes it is important that strategies used to tier drugs take into account the clinical efficacy as established through scientific evidence, the equivalence of alternatives, and the

cost implications to patients. Any step therapy policy must be supported by appropriate clinical practice guidelines developed by independent experts with knowledge of the condition or conditions under consideration, high quality research studies, or compelling evidence derived from observations made in medical practice, and not solely on the basis of economic reasons.

Moving vital medications (such as biologics) into higher level “specialty tiers” that require patients to pay a percentage of the actual cost of these drugs rather than a reasonable fixed co-payment can impact significantly the ability of patients to access the treatment they need, costing patients hundreds, and in some cases, even thousands, of dollars per month for a single medication. This can place medically necessary treatments out of reach for average Americans. Instead of having to pay a percentage-based co-insurance amount, CMSS supports limiting cost-sharing requirements in a specialty tier to the co-pay dollar amount applicable to drugs in a non-preferred brand tier. CMSS believes that limiting cost-sharing requirements for retail and physician administered medications to a reasonable fixed co-payment, rather than a percentage, would improve patient access to treatments and reduce financial disability while helping to constrain health care costs.

CMSS opposes the imposition by insurance companies of restrictive formularies that exclude medications considered necessary in the provision of high quality medical care. CMSS opposes any formulary that may operate to the detriment of patient care, such as those developed primarily to control costs. CMSS recognizes, however, that in special situations such as hospice, a patient may elect a benefit that offers expanded services along with an appropriately more limited formulary.

In the event a restrictive formulary is put in place, there should be a clear and timely appeals process through which physicians may prescribe and procure medications not in the formulary without penalty to their patients. Prior authorization and related appeals policies should not unduly burden physicians or patients in accessing optimal drug therapy. The process by which prior authorization determinations are made should be standardized and the speed of determination should be quantified and minimized. Excessive delays can cause irreparable harm to patients in need of specific treatments.

Compounding

CMSS supports continued patient and physician access to compounded and repackaged drug products prepared by licensed and accredited pharmacies. CMSS recommends that policymakers prioritize safety, while also seeking to eliminate barriers to access that are not supported by scientific evidence.

Generics and Biosimilars

CMSS supports removing barriers to the development and entry of generic drugs and biosimilars into the marketplace, which will increase competition and lower prices of pharmaceuticals. CMSS supports the establishment of policies or programs that may increase competition for brand-name and generic sole-source drugs. To increase marketability and availability of competitor products, CMSS supports enforcement of restrictions on “product-hopping”, “ever-greening”, and “pay-for-delay” practices.

With regard to biosimilars, chief concerns are safety and sufficient evidence of efficacy to support the substitution of biosimilars for brand name products. Once safety and efficacy are established, CMSS supports limiting “pay-for-delay” and excessive patent infringement lawsuits which will delay these therapies from coming to market.

CMSS recommends providing the FDA with added authority and the resources needed to expedite the review process to bring additional safe and efficacious medications and biologics to market. Doing so will provide more options for patients and increase competition in the marketplace.

In addition, the Federal Trade Commission should investigate the overpricing of drugs and enforce federal antitrust and consumer protection laws, where applicable.

Negotiating

CMSS supports studying the impact of allowing greater flexibility by Medicare and other publicly funded health programs to negotiate volume discounts on prescription drug prices and pursue prescription drug bulk purchasing agreements. CMSS also supports other potential strategic solutions that would facilitate the negotiation process as it pertains to drug pricing.

Value-based prescribing

CMSS supports research into novel approaches to encourage value-based decision making, including consideration of value frameworks, bundled payments, and indication-specific pricing.

CMSS recommends the consideration of evidence-based benefit designs of prescription medications included in a health plan’s benefit package, including explicit consideration of the pricing, cost, value, comparative effectiveness, and effectiveness of a medication in a specific patient.

Conclusion

CMSS prioritizes assuring access to needed prescription medications by not placing disproportionate economic burden on patients, encouraging informed patient participation in their health care decision making, and ensuring a realistically competitive marketplace.

Prescription medications have catalyzed significant progress in the treatment of disease. However, these therapies are only as effective as a patient’s ability to access them. CMSS calls for comprehensive efforts to implement meaningful policies to improve access to prescription medications to patients who need them most.

References

The CMSS Principles for Increasing Access to Needed Medications by Patients are drawn from and reflect the significant background work of many organizations, particularly the American College of Physicians1 and the American Academy of Dermatology Association.2

1. Stemming the Escalating Cost of Prescription Drugs: A Position Paper of the American College of Physicians, Hilary Daniel, BS, for the Health and Public Policy Committee of the American College of Physicians, published in the Annals of Internal medicine, March 29, 2016

2. Position Statement on Patient Access to Affordable Treatments, American Academy of Dermatology Association, November 7, 2015