LETTER OF MEDICAL NECESSITY

MEDICAL EXCEPTION TEMPLATE

The guidance presented here is for informational purposes only and is not intended to provide reimbursement or legal advice. AbbVie does not guarantee that the use of any information provided will result in coverage or payment by any third-party payer. You are responsible for the submission based on your clinical judgment.

For prescription approval, third-party payers may require physicians to submit documentation of Medical Necessity to support coverage of the prescribed treatment. A Letter of Medical Necessity documents a patient’s medical history and diagnosis, and provides a medical justification for the prescribed treatment.

What is included in a Letter of Medical Necessity:

  • Reason for request
  • Reason for denial
  • Rationale to address each reason for denial, including relevant clinical rationale where applicable
  • Relevant overall patient medical history and current condition
  • Relevant cost information (if known)
  • Summary of your professional opinion of likely outcome with the treatment
  • Restatement of request for approval

A Letter of Medical Necessity is usually submitted as part of a more comprehensive medical exception request package. Many physicians submit additional supporting documents to the payer, along with the Letter of Medical Necessity for clinical justification. Keep in mind the specific coverage policies and processes vary by payer.

Frequently Used Supporting Documents:

  • Any required appeal form from the insurer (if applicable)
  • Copy of the denial letter from the insurance company
  • Copy of the prescription
  • Patient’s signature on consent form for treatment
  • Patient’s complete medication profile including patient’s current, previous, and discontinued medications
  • Patient’s medical profile

YOUR DETAILS


PAYER DETAILS

State:


Denial Reason


PATIENT DETAILS


Gender:


Description of Patient's Medical History


My patient…

Clinical Considerations: Severe Renal Impairment

  • No dosage adjustment of MAVYRET is required in patients with mild, moderate or severe renal impairment, including those on dialysis.1
  • In EXPEDITION-4 a phase 3, open-label clinical trial evaluating the safety and efficacy of MAVYRET for 12 weeks in 104 GT 1–6 chronic HCV infected adults without cirrhosis or with compensated cirrhosis and stage 4 or 5 chronic kidney disease including those on dialysis, 98% (N=102/104) of patients achieved SVR12  and there were no virologic failures. The presence of renal impairment did not affect efficacy; no dose-adjustments were required during the trial.
  • The most common adverse reactions observed in greater than or equal to 5% of subjects receiving 12 weeks of treatment with MAVYRET were pruritus (17%), fatigue (12%), nausea (9%), asthenia (7%), and headache (6%).
  • In subjects treated with MAVYRET who reported an adverse reaction, 90% had adverse reactions of mild or moderate severity (Grade 1 or 2).
  • The proportion of subjects who permanently discontinued treatment due to adverse reactions was 2%.
  • For additional information on this topic, please contact AbbVie Medical Information (www.abbviemedinfo.com).

References:

1.     MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017.

 

Clinical Considerations: GT1 NS5A Experienced

  • MAVYRET is approved in patients with HCV genotype 1 infection who have had prior treatment experience with a NS5A inhibitor (NS3/4A protease inhibitor-naïve).1
  • The approved treatment duration in these patients, without cirrhosis or with compensated cirrhosis (Child-Pugh A), is 16 weeks of MAVYRET.
  • In the MAGELLAN-1 study, the SVR12 rate in HCV genotype 1 subjects who had failed prior treatment with NS5A inhibitors (NS3/4A protease inhibitor-naive) and were treated with MAVYRET for 16 weeks was 94% (16/17).
  • One patient experienced on-treatment virologic failure.
  • Due to higher rates of virologic failure and treatment-emergent drug resistance, the data do not support labeling for treatment of HCV genotype 1 infected patients who are both NS3/4A PI and NS5A inhibitor-experienced.
  • For additional information on this topic, please contact AbbVie Medical Information (www.abbviemedinfo.com).

Reference:

1.     MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017.

 

Clinical Considerations: Concomitant PPI Use

  • No dose adjustment is required when MAVYRET is coadministered with omeprazole.1
  • For additional information on this topic, please contact AbbVie Medical Information (www.abbviemedinfo.com).

Reference:

1.     MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017

 

Clinical Considerations: RBV-Free

  • MAVYRET is a ribavirin-free HCV regimen; it does not require coadministration with ribavirin.1
  • For additional information on this topic, please contact AbbVie Medical Information (www.abbviemedinfo.com).

References:

1.     MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017.

 

Clinical Considerations: HIV Co-infected

  • Dosing of MAVYRET is the same for patients with HCV/HIV-1 co-infection as it is for HCV-mono-infected patients.1
  • ENDURANCE-1 was a randomized, open-label study comparing the efficacy of 8 weeks of treatment with MAVYRET versus 12 weeks of treatment in non-cirrhotic subjects with genotype 1 infection who were either mono-infected with HCV or coinfected with HCV/HIV-1.
  • Thirty-three subjects coinfected with HIV were included in the study.
  • MAVYRET is contraindicated with atazanavir.
  • Efavirenz may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET. The use of efavirenz with MAVYRET is not recommended.
  • The use of darunavir, efavirenz, lopinavir, and ritonavir with MAVYRET is not recommended.
  • For additional information on this topic, please contact AbbVie Medical Information (www.abbviemedinfo.com).

Reference:

1.     MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017.

 

Clinical Considerations: Short Treatment Duration

  • MAVYRET is indicated for the treatment of adult patients with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A).1
  • An 8-week treatment duration for MAVYRET is FDA-approved for the following patients:
    • Treatment-naïve HCV GT 1-6 patients without cirrhosis
    • HCV GT 1, 2, or 4-6 patients without cirrhosis with prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A protease inhibitor or NS5A inhibitor
  • For additional information on this topic, please contact AbbVie Medical Information (www.abbviemedinfo.com).

Reference:

1.     MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017.

 

Medical Exception


Date: {{vm.todaysDate | date:'MM/dd/yyyy'}}
Payer Name: {{vm.payerFullName}}
Payer Address: {{vm.payerAddress}}
{{vm.payerCity}}, {{vm.payerState}} {{vm.payerZipCode}}

Payer Fax Number: {{vm.payerFaxNumber}}

Attn: {{vm.payerDepartment}}

Re: Coverage of {{vm.drugName}}
Patient Name: {{vm.patientFullName == 'The patient' ? '' : vm.patientFullName}}
Patient Date of Birth: {{vm.patientDOB}}
Patient Member ID: {{vm.patientMemberID}}

To whom it may concern,

I am writing to request approval of {{vm.drugName}} to treat my patient, {{(vm.payerFullName == 'The patient' ? '' : vm.payerFullName)}}. This product was denied on {{vm.payerDenialDate}} for the following reason(s): . for the following reason(s). {{vm.payerDenialReason}}

The patient {{vm.patientFullName}} is a {{vm.patientAge}}-year-old male female other who has been diagnosed with chronic HCV infection.

The patient {{vm.patientFullName}} was diagnosed with chronic HCV infection on {{vm.patientDiagnosedDate}}. The patient {{vm.patientFullName}} 's medical history includes {{vm.patientMedicalHistory}}.

Approval is being requested for {{vm.drugName}} based on my clinical opinion of the following clinical evidence and rationale:

If I can provide any additional information, please contact me at {{vm.phoneNumber}} to ensure the prompt approval of this course of treatment.

Regards,

{{vm.firstName}} {{vm.lastName}}



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