Persius/hicric huggingface dataset:
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Lapatinib 250 milligram tablet to treat metastatic tall cell thyroid cancer. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Promacta 25 milligram tablets to treat idiopathic thrombocytopenic purpura. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. This drug is being prescribed for a medically accepted indication. The plan has prior authorization requirements for this drug that must be met before coverage can be approved. The documentation submitted at reconsideration satisfies the plans coverage criteria. The prescriber has provided medical records for the date of July 21, 2022, which document the diagnosis of idiopathic thrombocytopenic purpura, a platelet count below 50,000, and refractory to steroids. A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is coverage for Nubeqa, 300 milligram tablet, 120 tablets per 30 days, to be given with androgen deprivation therapy (ADT), to treat metastatic castration-resistant prostate cancer. The Part D plan denied the request for coverage because the drug was being prescribed for a non-medically accepted indication. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.As outlined in the Medicare approved compendia and the Food and Drug Administration (FDA) product label, Nubeqa is not indicated for metastatic prostate cancer. However, the prescriber has submitted a peer-reviewed journal article from Lancet Oncology, a Medicare approved journal, titled Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. ODM-201 is another name for Darolutamide/Nubeqa. In this article, there was a positive outcome in those participants treated with Nubeqa for metastatic castration-resistant disease. As such, the submitted peer-reviewed journal article from a Medicare approved journal supports that the drug is being used for a medically accepted indication.The plans prior authorization requirement for the requested drug are as follows: the enrollee has non-metastatic castration-resistant prostate cancer and the drug will be given in combination with gonadotropin-releasing hormone (GnRH) analog or after bilateral orchiectomy. The records support the drug is going to be given in combination with a GnRH analog. Since the prescriber has submitted a peer-reviewed journal article from a Medicare approved journal that supports the use of Nubeqa in the treatment of metastatic castration-resistant prostate cancer, an exception is supported to the plans prior authorization requirement that the enrollees cancer must be non-metastatic. As such, the submitted documentation supports coverage for this drug. A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Rinvoq 45 milligram tablet extended release 24 hour to treat Crohn's disease of both small and large intestine with other complication. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Hizentra 10 milligram per 50 milliliter solution for subcutaneous infusion to treat antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia. The Part D plan denied the request for coverage. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The administration of Hizentra for the treatment of the noted condition would be covered under Medicare Part B. Drugs that are eligible for Part B coverage are excluded from Part D coverage by Medicare law. As such, the drug is excluded from Part D coverage.This decision does not address the medical necessity or appropriateness of the drug. It only establishes that payment cannot be made under the Medicare Part D benefit. Please submit the request for coverage through Medicare Part B.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Nifedipine 10 milligram capsule to treat hypertension and Raynaud's phenomenon. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried, failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives, required by the plan would likely not be as effective for this diagnosis, and/or would likely cause adverse reaction(s) or other harm.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Lidocaine 5 percent patch to treat chronic pain syndrome and chronic osteoarthritis of the left shoulder. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Kisqali 600 milligram daily dose tablets to treat metastatic breast cancer, hormone positive and HER2 negative, in an enrollee who has already experienced disease progression on cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitor therapy with Ibrance. The Part D plan denied the request for coverage.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. The plan has prior authorization requirements for this drug that must be met before coverage can be approved. The submitted documentation does not support that all of the plans requirements for coverage have been met. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Telmisartan-Hydrochlorothiazide 40-12.5 milligram tablet to treat essential hypertension. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives required by the plan would likely not be as effective for this diagnosis and/or would likely cause adverse reaction(s) or other harm. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Prevymis 480 milligram tablets for the prophylaxis of cytomegalovirus infection in an enrollee status post kidney transplant. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The plan has prior authorization coverage criteria that must be met prior to approval. The criteria indicates the enrollee must have a Food and Drug Administration approved indication. The Medicare approved compendia contain a citation to support the use of the drug for the enrollees noted diagnosis. The Food and Drug Administration has designated the drug at issue an orphan drug for the prophylaxis of cytomegalovirus infection in at risk enrollees. The enrollee received a second kidney transplant from a cytomegalovirus positive donor. The enrollee developed leukopenia on Valgancyclovir, and is at risk of organ rejection. Therefore, an exception to the plans coverage criteria is medically necessary.A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Favorable

At issue is Esbriet 267 milligram capsule to treat idiopathic pulmonary fibrosis. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The documentation satisfies the plans coverage criteria. At reconsideration, provider statement describes initial error in completing prior authorization information. Provider clarifies that there are no environmental exposure or explanation for pulmonary fibrosis. Furthermore, provided evidence of CT using Multiplanar and HRCT images with findings of the presence of honeycombing suggesting UIP ( interstitial pneumonia) pattern.A physician reviewed the appeal and determined that the requested drug is eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Eliquis 5 milligram tablet prescribed to reduce the risk of stroke and systemic embolism associated with atrial fibrillation. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. Eliquis is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception. A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Camzyos 5 milligram capsule to treat hypertrophic obstructive cardiomyopathy. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives required by the plan would likely not be as effective for this diagnosis and/or would likely cause adverse reaction(s) or other harm. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Saxenda 3 milligram per 0.5 milliliter subcutaneous pen injector to treat obesity. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.Drugs prescribed to treat weight gain (promote weight loss) are excluded from coverage under Medicare Part D. Therefore, the requested drug is excluded from coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Nurtec ODT (orally disintegrating tablet) 75 milligram tablet, 30 tablets per 30 days, to treat migraine headache. The plan approved coverage for this drug at a quantity of 18 tablets per 30 days. However, the plan denied the request for 30 tablets per 30-day supply.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. The plan limits the amount of Nurtec ODT 75 milligram orally disintegrating tablets provided to 18 tablets per 30 days. The following citation in DrugDex, a Medicare approved compendium, states: 'The safety of using more than 18 doses/30 days has not been established.' Therefore, an exception to the plans quantity limit is not supported.  A physician reviewed the appeal and determined that the Part D plan is not required to cover more than 18 tablets per 30 day-supply of the requested drug.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is coverage for Arikayce 590 milligram per 8.4 milliliter nebulizer solution to treat pulmonary Mycobacterium avium complex infection. The Part D plan denied the request for coverage.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level.The plan has coverage requirements for this drug that must be met before coverage can be extended. The submitted documentation does not confirm that the plans requirements for continued coverage have been met.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Sevelamer Carbonate 800 milligram tablet to treat secondary hyperparathyroidism of renal origin, renal osteodystrophy, disorders of phosphorus metabolism and phosphatases. The Part D plan denied the request.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D. Of note, a tiering exception cannot be granted for a drug that has not been approved for coverage.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Farxiga 10 milligram tablet to treat cyst of kidney, chronic kidney disease, hypertension, and type 2 diabetes with hyperglycemia. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. The requested drug is not on the plans formulary. In order to grant an exception for a drug not on the plans formulary, alternative formulary drugs must have been tried and failed, or deemed contraindicated. In this case, the documentation does not support why the formulary alternatives required by the plan would likely not be as effective for this diagnosis and/or would likely cause adverse reaction(s) or other harm. At reconsideration, it has been noted that the formulary alternative drugs, Invokana and Jardiance, are not appropriate to treat the enrollees condition. The reason given for this statement is that the requested drug, Farxiga, is being prescribed primarily to treat a cyst of kidney, along with the other co-morbid conditions including chronic kidney disease, hypertension, and type 2 diabetes with hyperglycemia. However, this is not a valid reason for a formulary exception, as the use of any of the noted drugs (Farxiga, Invokana, and/or Jardiance), which are all in the same drug class (sodium glucose co-transporter 2 inhibitors), to specifically treat a cyst of the kidney is not a medically accepted indication for the drug as outlined in the Medicare approved compendia. However, all of the drugs are medically accepted to treat type 2 diabetes in enrollees with coronary artery disease. As such, a formulary exception is not supported.  A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Tetrabenazine 25 milligram tablet to treat schizophrenia. The Part D plan auto-forwarded the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug is not eligible for coverage under Medicare Part D. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Dicyclomine Hydrochloride 20 milligram tablet to treat unspecified diarrhea, change in bowel habits, and nausea. The Part D plan denied the request.  We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. The noted conditions are off-label uses for the requested drug. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of these conditions. Therefore, the drug is being prescribed for non-medically accepted indications. A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Invokana 300 milligram tablet to treat type 2 diabetes mellitus. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan and any information submitted at the reconsideration level. Invokana is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception. A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Eliquis 5 milligram tablet prescribed to reduce the risk of stroke and systemic embolism associated with atrial flutter/fibrillation in an enrollee with a prior stroke. The Part D plan denied the request. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level. Eliquis is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, this drug is not eligible for a tiering exception. A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is a tiering exception request for Trijardy XR (extended release) 25-5-1000 milligram tablet to treat diabetes mellitus. The Part D plan auto-forwarded the case to us for review. We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted. Trijardy XR is a brand drug on Tier 3 of the plans formulary. There are no brand drugs of the same type on the lower tiers of the plans formulary to treat the same diagnosis. Therefore, the requested drug is not eligible for a tiering exception. A physician reviewer determined that the tiering exception criteria are not met.
Appeal type: Prescription Drug
Decision: Unfavorable

At issue is Levalbuterol Hydrochloride 0.63 milligram per 3 milliliter vial for nebulization to treat respiratory failure.The case was auto-forwarded by the plan.We received the case to perform an independent and de novo review. To make our decision, we reviewed all documentation submitted, including the case file from the plan, and any information submitted at the reconsideration level.The use of the requested drug to treat the provided diagnosis is an off-label use. The Medicare approved compendia do not contain any citations to support the use of the requested drug, as prescribed, for the treatment of this diagnosis. Therefore, the requested drug(s) is not eligible for coverage under Medicare Part D.A physician reviewed the appeal and determined that the requested drug is not eligible for Part D coverage.