Standard Reporting Form, Requests for Information, and Attestation Form

(1) Any Referred Manufacturer shall: provide its own estimation of the value of the Drug and supporting information, such as existing analyses; submit any additional data or documents that the Referred Manufacturer considers to be pertinent to the Commission's review; complete and submit a Standard Reporting Form; and respond to any requests for additional information within 30 days of receipt of the written notice or request or such other time frame as may be agreed upon, in writing, between the Referred Manufacturer and the Commission, through the Executive Director. (2) The Standard Reporting Form shall be developed and updated from time to time by the Commission, with advance notice to and input from Manufacturers and other interested stakeholders, and shall be made publicly available on the Commission's website. (3) The Standard Reporting Form shall include requests for information relating to the value and pricing of a Drug including, but not be limited to: (a) information on clinical efficacy, effectiveness and outcomes of the Drug, including clinical information submitted by the Referred Manufacturer to the U.S. Food and Drug Administration or successor agency; (b) a schedule of the Drug's wholesale acquisition cost and cost increases over the previous five calendar years; (c) information regarding the Drug's prices, net of rebates, internationally, nationally, and in Massachusetts; (d) information to support the Referred Manufacturer's pricing of the Drug; (e) information on utilization of the Drug; (f) financial information for the Referred Manufacturer in the aggregate and for the Drug, using the best information available including, but not limited to: 1. the Referred Manufacturer's research and development budget and expenditures including, but not limited to, the Referred Manufacturer's aggregate, company-level research and development and other relevant capital expenditures, including facility construction, for the most recent year for which final audited data are available; 2. the funding sources for the Referred Manufacturer's research and development expenditures, including identification of any public funding received; 3. information regarding the Referred Manufacturer's acquisition cost if the Drug was acquired; 4. the Referred Manufacturer's manufacturing, production and distribution budget and expenditures; and 5. the Referred Manufacturer's marketing budget and expenditures; and (g) a written, narrative description, suitable for public release, of factors that contributed to reported changes in wholesale acquisition cost and prices net of rebates during the previous five calendar years. (4) The Commission may request additional information that it deems necessary to identify such Drug's proposed value or a proposed Supplemental Rebate and a determination of whether the pricing of a Drug is unreasonable or excessive in relation to its value. (5) The Referred Manufacturer may submit to the Commission any additional data or information that the Referred Manufacturer considers to be pertinent to the Commission's review. (6) All data and information provided by a Referred Manufacturer shall be accompanied by a signed Attestation Form.