Appeal type: Prescription Drug
Decision: Unfavorable

You asked the Plan to cover Prolastin-C 1,000 mg/20 mL. The Plan did not grant this request. We received this case to conduct an independent review.We asked our Physician Reviewer to determine whether the Part D Plan was correct in denying the request for Prolastin C-Liquid 1000 mg/20 mL.Prolastin C-Liquid 1000 mg/20 mL is requested for treatment of this enrollee with severe chronic obstructive pulmonary disease/emphysema. Detailed medical records have been provided. The records indicate that this 66 year old man has a 43 pack year smoking history, and was still smoking one pack per day per a physician note February 26, 2020. Per the medical records, the enrollee's medical history includes, but is not limited to, severe obstructive lung disease with chronic hypercapneic/hypoxemic respiratory failure, centrilobular emphysema, obesity/hypoventilation syndrome, polycythemia, chronic rhinosinusitis, multiple environmental allergies, polycythemia, and coronary artery disease. Although the reconsideration request cover letter sent by the clinical appeals nurse at Eversana, and the Prolastin C prescription and enrollment form list the serum alpha-1 antitrypsin (AAT) level as 32.6 mg/dL, the actual laboratory report indicates that the AAT level is 32.6 micromoles/dL which per the physician note of 10/9/19 indicates is equivalent to 112 mg/dL with a PiMZ phenotype. (Reference range for the ATT level for the enrollee's phenotype is 14.6 - 33.0 uM). Pulmonary function tests performed February 6, 2019 were notable for an FEV1 of 29% predicted, and FEV1% of 39%. In summary, this 66 year old man with a significant smoking history has severe obstructive lung disease and multiple other co-morbidities. The request for reconsideration letter by the nurse at Eversana has incorrectly indicated that the enrollee has a markedly low ATT. The actual ATT level is as noted above with a phenotype that is only associated with a possible mild decrease in FEV1. Additionally, centrilobular emphysema is a pattern more often seen in smokers, and is not the typical pattern of emphysema associated with AAT deficiency; however there can be variability in the pattern of emphysema related to ATT deficiency.Based on the information provided, there is insufficient documentation that the enrollee has congenital alpha-1-antitrypsin deficiency as a cause of his severe COPD/emphysema. Consequently there is insufficient documentation that the requested drug is being prescribed for a medically accepted indication as defined by Medicare law. As such, an exceptions request based on medical necessity cannot be considered because the requested drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, the requested drug is not eligible for coverage under Medicare Part D based on the available documentation.Of note, the pulmonologist who did a thorough assessment of the enrollee's condition on October 9, 2019, stated in the medical records, I doubt he will benefit from alpha-1 antitrypsin augmentation. Of note, the request for reconsideration letter from the nurse at Eversana (the company that manages the Prolastin direct program) and the documents provided include the following: a statement that the enrollee has quit smoking (however there is no physician documentation that the enrollee has quit smoking), and medical literature - one study concluded that Pi MZ heterozygotes may be slightly more susceptible to the development of airflow obstruction than Pi MM individuals, another study demonstrated the benefits of AAT augmentation IN PATIENTS WITH SEVERE CONGENITAL ATT DEFICIENCY (i.e. PI*ZZ genotypes and combinations of Z, rare and null alleles expressing ATT serum concentrations of less than 11 micromoles or 50 mg/dl) - which is not applicable to the enrollee, and the FDA label for Prolastin which states that Prolastin is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary alpha-1 antitrypsin deficiency.For coverage under Part D, Medicare requires that the drug must be prescribed for a medically accepted indication. A medically accepted indication means a use that is approved by the FDA or a use that is supported by one or more citations in Medicare approved compendia. Our Physician Reviewer reviewed this file and determined that there are no citations in the Medicare approved compendia that support the use of Prolastin-C 1,000 mg/20 mL for the diagnosed condition. As a result, the drug is not being prescribed for a medically accepted indication as defined by Medicare law. As such, it cannot be covered under the Medicare Part D benefit for this condition. An exceptions request based on medical necessity cannot be considered because this drug, as prescribed, does not meet the definition of a Medicare Part D drug. Therefore, our decision is that the Plan is not required to provide coverage for Prolastin-C 1,000 mg/20 mL. This decision does not concern the medical necessity of the requested drug. It only establishes if payment can be made under the Medicare Part D benefit.