Table 21: Cystic Fibrosis Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Respiratory Agents
Medication Class/Individual Agents: Cystic Fibrosis Transmembrane Conductance Regulator Modulators
I. Prior-Authorization Requirements
Cystic Fibrosis Agents – Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Modulators |
Clinical Notes |
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Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself. ivacaftor
*Notes: Adjust dose for individuals with concomitant use of moderate and strong CYP3A inhibitors, moderate hepatic impairment, and use with caution in those with severe hepatic impairment. If possible, avoid concomitant use of CYP3A inducers (e.g., carbamazepine, rifampin, phenobarbital, phenytoin, St. John’s wort, etc).
lumacaftor/ivacaftor
**Notes: Adjust dose for individuals with hepatic impairment and concomitant use of strong CYP3A inhibitors (e.g., azole antifungals, clarithromycin, etc). If possible, avoid concomitant use of CYP3A inducers (e.g., carbamazepine, rifampin, phenobarbital, phenytoin, St. John’s wort, etc).
tezacaftor/ivacaftor
***Notes: Adjust dose for individuals with moderate or severe hepatic impairment or when coadministered with moderate or strong CYP3A inhibitors (e.g., azole antifungals, clarithromycin, etc).
elexacaftor/tezacaftor/ivacaftor
***Notes: Adjust dose for individuals with moderate hepatic impairment or when coadministered with moderate or strong CYP3A inhibitors (e.g., azole antifungals, clarithromycin, etc). Do not use in individuals with severe hepatic impairment or with concomitant strong CYP3A inducers (e.g., rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin, etc). References 1. Mogayzel PJ, Naureckas ET, Robinson KA, Mueller G, Hadjiliadis D, Hoag JB, et al. Cystic fibrosis pulmonary guidelines: chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013 Apr 1;187(7):680-9. |
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| PD | Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. |
II. Therapeutic Uses
FDA-approved, for example:
- treatment of cystic fibrosis (CF)
Note: The above list may not include all FDA-approved indications.
III. Evaluation Criteria for Approval
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
- All PA requests must include clinical diagnosis, drug name, dose, and frequency.
- A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
- For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
- Additional criteria may apply depending upon requested medication (see below).
Bronchitol
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ 18 years of age; and
- member has passed the Bronchitol Tolerance Test; and
- inadequate response, adverse reaction, or contraindication to Pulmozyme; and
- inadequate response, adverse reaction, or contraindication to sodium chloride for inhalation; and
- appropriate dose.
Kalydeco
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ four months of age; and
- request is within quantity limit of two units/day; and
- baseline body mass index (BMI) and percent predicted forced expiratory volume in one second (ppFEV1).
- For recertification, documentation of positive response to therapy (e.g., improvement in BMI, ppFEV1, decrease in clinical exacerbations) is required.
Orkambi
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ two years of age; and
- request is within quantity limit of four tablets/day or two packets/day; and
- baseline BMI and ppFEV1.
- For recertification, documentation of positive response to therapy (e.g., improvement in BMI, ppFEV1, decrease in clinical exacerbations) is required.
Symdeko
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ six years of age; and
- request is within quantity limit of two tablets/day; and
- baseline BMI and ppFEV1.
- For recertification, documentation of positive response to therapy (e.g., improvement in BMI, ppFEV1, decrease in clinical exacerbations) is required.
Trikafta
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ six years of age; and
- request is within quantity limit of three tablets/day; and
- baseline BMI and ppFEV1.
- For recertification, documentation of positive response to therapy (e.g., improvement in BMI, ppFEV1, decrease in clinical exacerbations) is required.
Original Effective Date: 04/2003
Last Revised Date: 08/2021
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Last updated 10/18/21