SPONSORED ARTICLE REGULATORY
• ONY Inc. v. Cornerstone Therapeutics and Chiesi Farmaceutici (W.D.N.Y., filed 2011) (dismissed on the basis that the CER study is a statement of scientific opinion, not a statement of facts; appeal dismissed by the Second Circuit, 2013), challenging publication of CER in a peerreviewed scientific journal);35 • Genzyme Pharmaceuticals v. Shire plc (D. Mass., filed 2012) (denial of motion to dismiss), challenging issuance of a press release describing the results of a head-to-head clinical trial with the plaintiff’s product, alleging the study was conducted for a different principal purpose; and • Ferring Pharmaceuticals v. Watson Pharmaceuticals (D.N.J., filed 2012), challenging allegedly false comparative statements at public presentations by a consultant, including regarding a patient survey, concerning the plaintiff’s product. The increasing development and dissemination of CER in response the demands of government and private payers can be expected to give rise to more of such competi-
tor litigation in the future. Consequently, CER should be carefully reviewed to ensure it is developed in accordance with prevailing scientific standards, and is disseminated either by including the entire article as published, with any summaries, press releases, or oral presentations focused on a factual recounting of the CER results.
Consequences of CER for Biopharma Growth and Investment
Cost-effectiveness research presents significant challenges for decisions regarding biopharma product development, promotion, investment, and mergers and acquisitions. Significant factors that will substantially affect payment and reimbursement include the potential for restrictions on Medicare or Medicaid coverage and reimbursement, and the potential of CER to mitigate such adverse consequences. Regardless of the status and use of CER by government payers, the acute interest by private payers illustrate that CER will increasingly be a crucial entry requirement for coverage and reimbursement for them, which biopharma manufac-
turers will have to address. Notwithstanding this emerging demand for CER, however, there is a significant potential for government enforcement action, primarily from FDA, from the use of CER in marketing and promotion. In addition, risks of competitor litigation challenging the dissemination of CER and its validity is also emerging as a significant potential risk to be addressed by biopharma manufacturers and product developers. These risks unavoidably present additional uncertainty regarding valuation of product candidates for research and development expenditures, and for decisions regarding potential investment, licensing and other collaboration agreements, and M&A for products and companies. Consequently, there is a much-heightened need to closely monitor and quickly adapt to regulatory and market changes and enforcement and litigation risks concerning the use of CER to properly assess payment and market access and sales expectations and undertake more informed valuations in making development, promotion, investment, and acquisition decisions.
1
See P. Neumann, et al., “Therapies for Advanced Cancers Pose a Special Challenge for Health Technology Assessment Organizations in Many Countries,” 31 Health Affairs 700 (April 2012)
search,” 31 Health Affairs 2200 (Oct. 2012); E. Perfetto, et al., “Communication About Results of Comparative Effectiveness Studies: A Pharmaceutical Industry View,” 31 Health Affairs 2213 (Oct. 2012). 12 See R. Temple, “A Regulator’s View of Comparative Effectiveness Research,” 9 Clinical Trials 56 (Feb. 2012) 13 Pink Sheet, June 3, 2013. 14 See 75 Fed. Reg. 57045 (Sept. 17, 2010) 15 Recently, Medtronic announced that its renal denervation device was one of the first products to be accepted for review under the Parallel Review program. See Regulatory Focus, March 7, 2013. 16 Pink Sheet, October 31, 2011 17 Pharmaceutical Law & Industry Report, May 25, 2010 18 Pink Sheet, October 25, 2010 19 Pink Sheet, March 26, 2012 20 Gray Sheet, May 28, 2012 21 A recent report by IMS Health concluded that “real-world evidence” is increasingly influencing how payers are making biopharma coverage and reimbursement decisions, summarized in the Pink Sheet, May 27, 2013. 22 M Olfson & S. Marcus, “Decline in Placebo-Controlled Trial Results Suggests New Directions for Comparative Effectiveness Research,” 32 Health Affairs 1116 (June 2013) 23 Scrip, Oct. 15, 2010
24 Scrip, Oct. 21, 2011 25 Scrip, May 4, 2012 26 Reuters, June 21, 2013 27 Scrip, Feb. 15, 2013 28 Pink Sheet, Jan. 14, 2013 29 Pink Sheet, Feb. 6, 2012 30 Scrip, Jan. 25, 2013 31 See J. Cohen, et al., “Compared to US Practice, EvidenceBased Reviews in Europe Appear to Lead to Lower Prices for Some Drugs,” 32 Health Affairs 762 (April 2013) 32 Note the comments stressing that CER needs to be incorporated early in the product development pipeline by the head of CER at Novartis Pharmaceuticals, summarized in the Pink Sheet, Dec. 12, 2011, and by the director of public policy at GlaxoSmithKline, summarized in the Pink Sheet, April 9, 2012 33 Pink Sheet, November 14, 2011 34 AstraZeneca has noted its focus on personalized medicine as partly intended to enhance cooperation with and decisions by managed care payers, as noted in Scrip, October 21, 2011 35 The author and his firm are counsel for the manufacturer defendants in this action.
2 3
Scrip, May 10, 2013 See D. Leonard, “CER ‘Substantial Impact’ Expected in Three-to-Five Years: NPC’s [National Pharmaceutical Council] Annual Comparative Effectiveness Survey,” RPM Report (March 2013)
4 5 6 7
Inside CMS, Sept. 29, 2011 Pink Sheet, Dec. 3, 2012 Pink Sheet, May 13, 2013 See M. Fischer and J. Avorn, “Academic Detailing Can Play a Key Role in Assessing and Implementing Comparative Effectiveness Research Findings,” 31 Health Affairs 2206 (Oct. 2012)
8 9
Pink Sheet, Sept. 5, 2011. Inside CMS, Nov. 10, 2011
10 J. of Am. Med. Ass’n, May 4, 2011 11 See, e.g., J. Griffin, et al., “Regulatory Requirements of the Food and Drug Administration Would Preclude Product Claims Based on Observational Research,” 31 Health Affairs 2188 (Oct. 2012); A. Kesselbaum and J. Avorn, “The Food and Drug Administration has the Legal Basis to Restrict Promotion of Flawed Comparative Effectiveness Re-
LMG LIFE SCIENCES 2013
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