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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Cystic Fibrosis Agents – Mucolytics |
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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.
- Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
- 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
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 both of the following: Pulmozyme, sodium chloride for inhalation; and
- appropriate dosing.
Kalydeco
- Documentation of all of the following is required:
- appropriate diagnosis; and
- member is ≥ one month of age; and
- requested quantity is ≤ two units/day; and
- baseline body mass index (BMI); and
- for members > six years of age, baseline 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 ≥ one year of age; and
- one of the following:
- for tablets, requested quantity is ≤ four tablets/day; or
- for granules, requested quantity is ≤ two packets/day; and
- baseline BMI; and
- for members > six years of age, baseline 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
- requested quantity is ≤ two tablets/day; and
- baseline BMI; and
- for members > six years of age, baseline 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 ≥ two years of age; and
- one of the following:
- for tablets, requested quantity is ≤ three tablets/day; or
- for granules, requested quantity is ≤ 2 packets/day; and
- baseline BMI; and
- for members > six years of age, baseline 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: 03/2024
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Last updated 04/01/24