(a) In
determining whether to enter into direct negotiations with a manufacturer, or
whether to enter into an SRA as a result of such negotiations, EOHHS may
consider the following factors, as applicable, provided that EOHHS's
consideration of such factors is consistent with the principles set forth in
801 CMR
21.01:
Purpose, Application and
Authority:
1. Information regarding
the clinical efficacy, effectiveness, and outcomes of the covered
drug;
2. Information relating to
the pricing of the covered drug including, but not limited to, information
relating to prices paid in other countries;
3. The covered drug's post-rebate price to
the Medicaid program as compared to its therapeutic benefits including, but not
limited to, the seriousness and prevalence of the disease or condition that is
treated by the drug, and the extent to which the drug addresses an unmet
medical need or impacts affected patient subpopulations;
4. The extent of utilization or expected
utilization of the covered drug within the Medicaid population;
5. The likelihood that the use of the covered
drug will reduce the need for other care, reduce caregiver burden, or enhance
quality of life;
6. Whether there
are therapeutic equivalents of the covered drug, and the number of such
equivalents available;
7.
Characteristics of the covered drug, including means and setting of
administration, dosing frequency, duration of therapy, side effects,
interactions and contraindications, and potential for misuse or
abuse;
8. Analyses by independent
third parties, provided that EOHHS will consider, as available, the
methodologies and models used in the analysis, any assumptions and potential
limitations of the analysis, and outcomes for specific subpopulations, if
applicable;
9. The extent to which
the manufacturer of the covered drug has entered into other SRAs;
10. Any information supplied by the
manufacturer; and
11. Other
appropriate measures or analysis related to the value, efficacy, or outcomes of
the covered drug.
(b) If
EOHHS engages a third-party to provide a cost-effectiveness analysis in
evaluating whether to enter into an SRA, the analysis must include:
1. a description of the methodologies and
models used in the analysis;
2. any
assumptions and potential limitations of the analysis; and
3. outcomes for specific subpopulations, if
applicable.
(c) EOHHS
may, provided that doing so is consistent with its obligations under 101 CMR
801.03(1)(b), share with the manufacturer for review and input during the
course of a direct negotiation any information, analyses, or reports regarding
a covered drug relied on by EOHHS in developing an offer or counter offer for
an SRA, and will consider any information provided by the manufacturer in
response. Subject to 101 CMR 801.04(2)(e), nothing will compel EOHHS to share
such information with the manufacturer during the direct negotiation
process.