; (ii) if administered in accordance with the labeling of such drug, is expected to result in either— (I) the cure of such disease or condition; or (II) a reduction in the symptoms of such disease or condition to the extent that such disease or condition is not expected to lead to early mortality; and (iii) is expected to achieve a result described in clause (ii), which may be achieved over an extended period of time, after not more than 3 administrations. (D) Relevant clinical parameter The term relevant clinical parameter means, with respect to a covered outpatient drug that is the subject of a risk-sharing value-based payment agreement— (i) a clinical endpoint specified in the drug’s labeling or supported by one or more of the compendia described in section 1861(t)(2)(B)(ii)(I) that— (I) is able to be measured or evaluated on an annual basis for each year of the agreement on an independent basis by a provider or other entity; and (II) is required to be achieved (based on observed metrics in patient populations) under the terms of the agreement; or (ii) a surrogate endpoint (as defined in section 507(e)(9) of the Federal Food, Drug, and Cosmetic Act), including those developed by patient-focused drug development tools, that— (I) is able to be measured or evaluated on an annual basis for each year of the agreement on an independent basis by a provider or other entity; and (II) has been qualified by the Food and Drug Administration. (E) Risk-sharing value-based payment agreement The term risk-sharing value-based payment agreement means an agreement between a State plan and a manufacturer— (i) for the purchase of a covered outpatient drug of the manufacturer that is a potentially curative treatment intended for one-time use; (ii) under which payment for such drug shall be made pursuant to an installment-based payment structure that meets the requirements of paragraph (3); (iii) which conditions payment on the achievement of at least 2 relevant clinical parameters (as defined in subparagraph (C))