American patients with cancer and their physicians can choose from a wide range of drug options through Medicare Part B coverage, but patients in other countries—like England—are often limited by the decisions made through a health technology assessment (HTA) process involving cost-effectiveness analysis.

To better understand how a centralized HTA process impacts patient access and provider choice of physician-administered medicines, Avalere compared the breast cancer therapies utilized by Medicare Part B beneficiaries to HTAs performed by England’s National Institute for Health and Care Excellence (NICE). In 2017 and 2018, over 125,000 Medicare Part B fee-for-service (FFS) beneficiaries with breast cancer received a physician-administered drug therapy. Over 70,000 of them received a therapy that was not approved for routine NHS coverage or for experimental use within England’s CDF.¹ As a result, if NICE recommendations were used to determine which breast cancer therapies were covered for Medicare Part B beneficiaries, 56% of beneficiaries would not have had coverage for the therapies their physicians prescribed.

Avalere reviewed NICE HTA reports for breast cancer therapies approved by the European Medicines Agency (EMA) between 2000 and 2018 to identify those therapies that did not receive a positive recommendation by NICE, which deems them ineligible for routine coverage in NHS England or for experimental use in England’s CDF. The analysis identified 10 physician-administered oncology drugs covered by Medicare Part B for which coverage in NHS and the CDF was restricted due to the NICE review process.

NICE was established in 1999 to conduct economic evaluations of healthcare interventions and cost-effectiveness appraisals to recommend if and how medicines should be used in order to help NHS England prioritize the use of limited resources. Starting in 2016, a positive NICE recommendation became a prerequisite for routine oncology treatment coverage by NHS England or for experimental coverage by England’s CDF. In the US, Medicare Part B covers any oncology physician-administered drugs that are “reasonable and necessary.”

As policymakers show continued interest in reducing spending and improving affordability for prescription medicines, some have proposed the adoption of policies and pricing decisions from other countries. Proposals that seek to tie Medicare reimbursement to drug prices in other nations or link drug coverage decisions to a centralized HTA process have emerged in recent years but raise concerns about curbing coverage of therapies and limiting patient and provider choice. Policymakers considering drug pricing solutions in the US will likely have to balance between their policy goals and the potential impact on patient access and patient-provider personalized decision-making.

Methodology

Avalere performed this analysis using Medicare Part A/B FFS claims under a Centers for Medicare & Medicaid Services research-focused data use agreement. All eligible Medicare Part B beneficiaries receiving active treatment for breast cancer were included, which represented less than 20% of total Medicare beneficiaries. Avalere also researched HTA reports from the NICE technology appraisal guidance website and EMA authorizations from the EMA website.

Avalere examined the use of cancer therapies in Medicare Part B FFS claims and matched them to the NICE HTA reports. Only therapies with positive NICE HTA recommendations would be considered routinely covered, starting on the publication dates of the HTAs. EMA-authorized therapies without a positive NICE HTA would be considered not covered or not covered for the time period before a positive NICE HTA was put into place. Based on this logic, Avalere determined that 10 Part B drugs would have had coverage restricted for Medicare beneficiaries if the NICE HTA decisions were applied. Both chemotherapies and endocrine therapies were included in cases of active treatment of breast cancer, which excludes prophylactic endocrine treatments.

To calculate the numerator of unique beneficiaries who received drugs in the US that would not be covered by NHS England or the CDF, Avalere identified Medicare Part B beneficiaries with a primary breast cancer diagnosis code who received a “not covered” therapy based on the therapeutic criteria (e.g., adjuvant status, combinations, therapy line of therapy) described in the NICE HTAs. Some Medicare beneficiaries might have received multiple “not covered” therapies, but in these cases each beneficiary was only counted once. To calculate the denominator of all unique beneficiaries receiving drug therapies for the treatment of active breast cancer, Avalere identified all Medicare Part B beneficiaries with a primary breast cancer diagnosis code who received any Part B chemotherapy or endocrine treatment between 2017 and 2018.

Funding for this research was provided by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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Notes

1. Prior to 2016, cancer patients in NHS England could receive cancer therapies without a positive NICE recommendation through England’s CDF.