Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway

Holtzman, Jessica N.; Kramer, Daniel B.

doi:10.1177/1073110518822005

Cited by 5 publications

(3 citation statements)

References 16 publications

(15 reference statements)

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“…76 However, few companies have pursued the pathway, reflecting concerns that parallel review could delay market entry because CMS may require more complex study designs (e.g., involving patients with multiple comorbidities or longer follow-up times). 77 In 2016, the FDA created a Payor Communication Task Force to help device companies meet requirements of regulators and payers, 9,78 though information on the use or impact of this program has not been made publicly available. 79 The challenge is to foster earlier communication without creating new hurdles.…”

Section: Promoting Earlier Discussion Among the Fda The Cms And Drug ...mentioning

confidence: 99%

“…For over a decade, the FDA and CMS have offered a voluntary “parallel review” option for devices under which the agencies provide simultaneous reviews 76 . However, few companies have pursued the pathway, reflecting concerns that parallel review could delay market entry because CMS may require more complex study designs (e.g., involving patients with multiple comorbidities or longer follow‐up times) 77 . In 2016, the FDA created a Payor Communication Task Force to help device companies meet requirements of regulators and payers, 9,78 though information on the use or impact of this program has not been made publicly available 79…”

Section: Improving the Handoff: Options And Recommendationsmentioning

confidence: 99%

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Improving Food and Drug Administration–Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval

NEUMANN,

CRUMMER,

CHAMBERS

et al. 2023

Milbank Quarterly

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Policy Points The increasing number of drugs granted accelerated approval by the Food and Drug Administration (FDA) has challenged the Medicare program, which often pays for expensive therapies despite substantial uncertainty about benefits and risks to Medicare beneficiaries. We recommend several administrative and legislative approaches for improving FDA–Centers for Medicare and Medicaid Services (CMS) coordination around accelerated‐approval drugs, including promoting earlier discussions among the FDA, the CMS, and drug companies; strengthening Medicare's coverage with evidence development program; linking Medicare payment to evidence generation milestones; and ensuring that the CMS has adequate staffing and resources to evaluate new therapies. These activities can help improve the integrity; transparency; and efficiency of approval, coverage, and payment processes for drugs granted accelerated approval. ContextThe Food and Drug Administration (FDA)’s accelerated‐approval pathway expedites patient access to promising treatments. However, increasing use of this pathway has challenged the Medicare program, which often pays for expensive therapies despite substantial uncertainty about benefits and risks to Medicare beneficiaries. We examined approaches to improve coordination between the FDA and Centers for Medicare and Medicaid Services (CMS) for drugs granted accelerated approval.MethodsWe argue that policymakers have focused on expedited pathways at the FDA without sufficient attention to complementary policies at the CMS. Although differences between the FDA and CMS decisions are to be expected given the agencies’ different missions and statutory obligations, procedural improvements can ensure that Medicare beneficiaries have timely access to novel therapies that are likely to improve health outcomes. To inform policy options and recommendations, we conducted semistructured interviews with stakeholders to capture diverse perspectives on the topic.FindingsWe recommend ten areas for consideration: clarifying the FDA's evidentiary standards; strengthening FDA authorities; promoting earlier discussions among the FDA, the CMS, and drug companies; improving Medicare's coverage with evidence development program; tying Medicare payment for accelerated‐approval drugs to evidence generation milestones; issuing CMS guidance on real‐world evidence; clarifying Medicare's “reasonable and necessary” criteria; adopting lessons from international regulatory‐reimbursement harmonization efforts; ensuring that the CMS has adequate staffing and expertise; and emphasizing equity.ConclusionsBetter coordination between the FDA and CMS could improve the transparency and predictability of drug approval and coverage around accelerated‐approval drugs, with important implications for patient outcomes, health spending, and evidence generation processes. Improved coordination will require reforms at both the FDA and CMS, with special attention to honoring the agencies’ distinct authorities. It will require administrative and legislative actions, new resources, and strong leadership at both agencies.

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Section: Promoting Earlier Discussion Among the Fda The Cms And Drug ...mentioning

confidence: 99%

Section: Improving the Handoff: Options And Recommendationsmentioning

confidence: 99%

Improving Food and Drug Administration–Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval

NEUMANN,

CRUMMER,

CHAMBERS

et al. 2023

Milbank Quarterly

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“…Although the pharmaceutical and medical technologies business literature has grown in recent years, the medical device business has received little attention. The majority of articles and reports add medical devices to the general section of life science (DiMasi et al , 2003; Rubin et al , 2015; Angeli and Jaiswal, 2016; Holtzman and Kramer, 2018). Nevertheless, there are medical device companies that are successful in the international market, with impressive experience in creating and capturing value that could be useful for medical device start-ups and other market participants.…”

Section: Introductionmentioning

confidence: 99%

The importance of financial resources and ownership of intellectual property rights for university spin-offs: the cases of Finland and Sweden

Kulkov

Berggren

Eriksson

et al. 2020

JSBED

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PurposeThis paper focuses on medical device university spin-offs (USOs), taking into account the peculiarities of financial and nonfinancial support and intellectual property rights (IPRs). The authors declare that these parameters play a significant role in business development at the early stages.Design/methodology/approachThis empirical data consist of individual and group interviews in Finland and Sweden, which are later inductively analyzed.FindingsThe results show that public financial support contributes to the formation and start of sales stages in small countries and local markets. However, at the validation stage, approaches for supporting entrepreneurship in the field of medical devices may differ. The ownership of IPRs assists in the development of entrepreneurship in the region due to the transfer of research results and researchers to the industry and increases the number of spin-offs and the cooperation of universities with business.Originality/valueThis contribution is in the identification of the key parameters for the formation, support and development of the USOs from the point of view of the availability of financial resources and the ownership of IPRs.

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Compulsory Medical Device Registries

Parasidis¹,

Kramer²

2022

The Future of Medical Device Regulation

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Harmonizing Standards and Incentives in Medical Device Regulation: Lessons Learned from the Parallel Review Pathway

Cited by 5 publications

References 16 publications

Improving Food and Drug Administration–Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval

Improving Food and Drug Administration–Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval

The importance of financial resources and ownership of intellectual property rights for university spin-offs: the cases of Finland and Sweden

Compulsory Medical Device Registries

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