Access to Appropriate, Affordable Care
Oral Oncology Parity
Injected and infused therapies tend to be covered generously under a health plan’s medical benefit, while oral therapies are often less favorably covered under the plan’s pharmacy benefit. Celgene strongly supports oral oncology parity laws that provide patients more affordable access to treatments, regardless of how the treatment is administered.
Step Therapy Reform
Health insurance companies are increasingly employing utilization management policies such as step therapy (a.k.a. “fail first” policies) that limit the use of prescription medicines. Step therapy forces patients to fail therapies preferred by the health plan before patients can access the medicines their providers select. Celgene supports public policies that ensure that health plan utilization management protocols are clinically appropriate, transparent, and allow for physician/patient choice based on the medical needs of the individual patient.
Increasing Access and Affordability for Patients in the Part D Program
Medicare Part D provides comprehensive prescription drug coverage to Medicare beneficiaries. Surveys of Part D enrollees find that they are highly satisfied with the program. Through competition and choice, Medicare Part D continues to save money for both the government and Part D enrollees, while providing critical access to medicines for older Americans.
At the same time, beneficiary cost sharing in Part D continues to increase, potentially placing medication adherence and beneficiary outcomes in jeopardy. Celgene supports maintaining the current, fundamental structure of the program, including the important access protections that exist for patients with life-threatening diseases like cancer. In addition, Celgene supports modernizing the Part D benefit to bring it into alignment with other types of insurance, specifically by creating an annual out-of-pocket cap to protect beneficiaries with the greatest medical needs from burdensome cost sharing.
Preserving Access in Medicare Part B
Many patients access life-saving medicines through Medicare Part B. Importantly, Part B affords beneficiary and provider choice – allowing patients and physicians to select the most appropriate treatments. Beneficiary and physician choice should remain a cornerstone of the Part B program, and any policy changes in Part B should preserve both access to treatment options and providers’ ability to purchase and administer complex medicines to their patients.
Focusing the 340B Program on the Patients It Was Created to Serve
Safety net providers play a critical role in delivering care to vulnerable populations. However, the 340B program has expanded far beyond its original focus on low-income and uninsured patients, and has instead created an opportunity for providers to obtain deep discounts on prescription drugs through corporate and contractual changes. We support targeted updates to definitions (e.g., the definition of “patient”) and standards to refocus the 340B program on the patients it was originally intended to serve.
Recognizing and Rewarding Value
Access to Therapies Using Novel Scientific Technologies
New therapies, including chimeric antigen receptor T cell (CAR T) therapy, are changing how we think about cancer care. It is critical that all patients who need these therapies, including those covered by public programs like Medicare and Medicaid, have access to advanced treatment options that use new scientific platforms. Celgene supports appropriate reimbursement for providers who deliver these novel therapies regardless of the care setting.
Innovative contracting models such as indication-based pricing, outcomes-based contracts, and other designs, can promote paying for value when appropriately designed. Celgene supports market-driven innovation in payment and contracting, along with specific public policy changes to enable bolder collaboration among biopharmaceutical companies, payers, and providers.
Alternative Payment Models
Healthcare payment models continue to evolve, with an increasing focus on total cost of care, risk sharing, and population health. For example, CMS’ Oncology Care Model provides episode-based reimbursement for cancer care. Celgene supports payment models that promote coordination and quality of care while safeguarding patient access to the most appropriate treatment options.
Value of Prescription Medicines
Measuring the value of prescription medicines is complex and involves many factors. Celgene is committed to pricing our products based on value, and contributing to the value that medical innovation brings to patients, the health system, and society.
We oppose price controls that arbitrarily separate pricing from value and limit biopharmaceutical companies’ ability to reinvest in the next generation of treatments. We recognize that stakeholders want more information about the value and price of medicines, and we have published pricing principles and a Value and Innovation Framework Report to increase transparency. While we are eager to share our perspective, we also have strong concerns with proposed transparency legislation that requires the disclosure of proprietary information or distorts market incentives through the publication of competitively sensitive material.
Ensuring Patient Safety
Celgene is resolutely committed to patients, their families, providers, and public health. Celgene’s groundbreaking products – Thalomid, Revlimid, and Pomalyst – all carry the risk of significant side effects, including severe birth defects. Even a single dose of thalidomide, the active ingredient in Thalomid, can cause irreversible, debilitating birth defects if not properly handled and dispensed. Revlimid and Pomalyst are believed to have similar risks. Therefore, these therapies are subjected to rigorous safety controls that have been developed by the company and approved by the FDA. Since we introduced these products, those rigorous safety measures have ensured the safe use of these medicines without an incident of a severe birth defect of the type associated with thalidomide.
Celgene supports federal legislative and regulatory action that provides for innovators to sell samples for testing to prospective generic applicants on commercially reasonable terms while ensuring appropriate safety and liability protections.
Such policies must include a robust process for FDA review and authorization of the safety protections that will be implemented by generic manufacturers. We are supportive of finding a solution and look forward to continuing to work with the Administration and Congress to ensure patients can safely access the medicines they need.
More information on our REMS program and practices regarding the sale of samples can be found here.
Protecting Intellectual Property
Strong intellectual property protections enable innovators to invest in new treatments and provide new options for patients. Celgene is among the highest of any large company in any industry anywhere in the world in the percentage of revenue reinvested in research and development, and we support public policies that support our ability to pursue the therapies of tomorrow.