(c)

1. (1) The office shall produce an annual report on trends related to access, affordability and spending on pharmaceutical drugs in the commonwealth and other reports from time to time. The annual report shall address such trends and underlying factors for pharmaceutical drug spending, including an analysis of trends in:

(2) The annual report shall be based on factors, including, but not limited to:

1. (i) drug pricing;
2. (ii) the impact of aggregate manufacturer rebates, discounts and other price concessions on net drug pricing;
3. (iii) patient cost-sharing such as deductibles, coinsurance, copayments or similar charges paid by patients for drugs;

4. (iv) the impact of aggregate rebates, discounts and other price concessions on such cost-sharing; and (v) the impact of utilization management techniques on pharmaceutical access employed by payers, including tiering, prior authorization and step therapy. The annual report shall be informed by:

   1. (A) the office's analysis of information provided at the annual cost trends hearing by providers, provider organizations and payers;
   2. (B) data collected by the center under sections 8 to 10A, inclusive, of chapter 12C; and (C) any other information available to the commission that is necessary to fulfill its duties under this section, as further defined in regulations promulgated by the commission.

(3) The office shall consult with the rare disease advisory council established pursuant to section 241 of chapter 111 and other stakeholders as determined by the office for any analysis the office performs pursuant to section 8A of a drug that is prescribed to treat a rare disease or is otherwise designated as a first-in-class drug by the United States Food and Drug Administration's Center for Drug Evaluation and Research. Such analysis shall include:

1. (i) the disease treated by the drug;
2. (ii) the severity of disease treated by the drug;
3. (iii) the unmet medical need associated with the disease treated by the drug;
4. (iv) the impact of particular coverage, cost-sharing, tiering, utilization management, prior authorization, medication therapy management or other utilization management policies on access to the drug and on patients' adherence to the treatment regimen prescribed or otherwise recommended by their health care provider;
5. (v) an assessment of the benefits and risks of the drug for patients;
6. (vi) whether patients who need treatment from or a consultation with a rare disease specialist or a specialist in the disease being treated by the first-in-class drug have adequate access and, if not, what factors are causing the limited access; and
7. (vii) the demographic and the clinical description of patient populations.

(d) The office shall analyze records related to pharmaceutical pricing disclosed to the commission pursuant to section 8A and assist the commission in identifying proposed supplemental rebates for eligible drugs under said section 8A. The office's analysis of such records shall consider:

1. (i) the effectiveness of the drug in treating the conditions for which it is prescribed;
2. (ii) improvements to a patient's health, quality of life or overall health outcomes; and (iii) the likelihood that use of the drug will reduce the need for other medical care, including hospitalization.
3. (e) The office may consult with external experts or other third-party entities when the office lacks the specific scientific, medical or technical expertise necessary for the performance of its responsibilities under this section; provided, however, that the commission shall disclose when such external expert or third-party entity contributes to its analysis and reporting and the identity of such external expert or third-party entity.