Source: Pharmac
Many responders were supportive of the proposal to fund an additional brand of budesonide with eformoterol, noting that:
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PHARMAC has noted these supportive responses. |
Some responders were concerned whether this would be funded for use as Anti-inflammatory reliever (AIR) and AIR plus maintenance therapy |
PHARMAC understands that the budesonide with eformoterol 160/4.5 product (200/6) will be Medsafe-approved for use as:
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Some responders noted that this is another dry powder inhaler (DPI) and that feedback from both health professionals and patients has indicated that a metered dose inhaler device is preferred. They queried if PHARMAC should enable Vannair, the currently funded budesonide with eformoterol pMDI to be used as anti-inflammatory reliever or anti-inflammatory reliever plus maintenance therapy. |
Vannair is not Medsafe-approved for use as SMART or AIR therapy. PHARMAC understands that there are no budesonide with eformoterol pMDI products that have Medsafe approval for anti-inflammatory reliever or anti-inflammatory reliever plus maintenance therapy at this time. We will continue to liaise with suppliers and monitor the regulatory setting for any approvals of any budesonide with eformoterol pMDI products for the AIR or AIR plus maintenance therapeutic indications. |
Some responders noted that the listing of DuoResp Spiromax would add an additional inhaler to an already large list of inhalers available in NZ. |
Noted, however as stated in the consultation, the intention here is to introduce and promote competition in the budesonide with eformoterol market. |
Some responders considered that the addition of an inhaler with an expiry of 6 months to be a risk, and noted that the DuoResp Spiromax product must be discarded within 6 months of removing from the foil wrapping, rather than discarded upon the shelf-life of the product expiring. |
PHARMAC considers it important that healthcare professionals explain how these inhalers are used and that these should not be used for longer than 6 months once opened. This information is clearly indicated on the packaging of each inhaler. It is considered important that pharmacists, prescribers, practice nurses, and others in the healthcare team communicate to patients that there is an expiry of 6-months from the date of opening of the product (similar to insulin and eye drops). We note the importance of pharmacists reminding patients to note the date when they remove the inhaler from the foil to track the six-month expiry. |
Some responders noted that as there are only 2 strengths available, there is a decreased ability to down-titrate for this product. |
PHARMAC notes this, however Teva Pharma does not currently have a product that is equivalent to the Symbicort Turbuhaler 100/6, and therefore, this has not been included. |
Some responders queried exactly how much lactose is in each of the DuoResp Spiromax products. |
Lactose is an inactive ingredient to ensure consistent dosing commonly used in many dry powder inhalers. DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder contains approximately 5 milligrams of lactose per dose (as monohydrate). This has been taken from the SmPC for this product (smpc)(external link). DuoResp Spiromax 320 micrograms / 9 micrograms inhalation powder contains approximately 10 milligrams of lactose per dose (as monohydrate). This has been taken from the SmPC for this product (smpc)(external link). This amount of lactose does not normally cause problems in lactose intolerant people. If allergic to lactose, patients should speak to their healthcare professional about alternative inhaler options. |
Some responders queried what the lung deposition of budesonide and eformoterol from this product is, and if it is similar to the currently listed budesonide with eformoterol products. |
DuoResp Spiromax has been shown to be equivalent to Symbicort Turbuhaler in both pulmonary and systemic deposition for the equivalent 200/6 and 400/12 doses. PHARMAC understands that pharmacokinetic studies have shown DuoResp Spiromax to be equivalent to Symbicort Turbuhaler in both pulmonary and systemic deposition for the equivalent 200/6 and 400/12 doses. Members of the Respiratory Subcommittee consider these studies to be a valid surrogate for evaluating regional lung deposition. Members of the Respiratory Subcommittee of PTAC consider that clinically important differences in regional lung distribution are not expected between pMDIs and DPIs, as the clinical outcome studies are good with both devices. However, members acknowledge they were unable to find any available direct comparisons between DuoResp Spiromax and Vannair. |
Some responders recommended that the high strength (400/12) product not be funded, as an active recommendation in the NZ asthma guidelines is made that it not be used as anti-inflammatory reliever therapy. Noted that there is a risk that the 400/12 product might be used for reliever therapy, which would expose the patient to significant risk from excessive dosing of both the inhaled corticosteroid (ICS) and long acting beta agonist (LABA) components |
The Symbicort Turbuhaler 400/12 presentation was listed in the Pharmaceutical Schedule in 2006, and the DuoResp Spiromax 320/9 (400/12) is considered equivalent. There remains a number of patients prescribed this strength, and PHARMAC considers it would be difficult at this stage to exclude this apparent high-need population, who are apparently benefitting from being prescribed the high strength formulation, from any potential commercial process for this market without further clinical advice. In addition, there is a dispensing restriction on the 400/12 strength of Symbicort Turbuhaler, restricting its use to no more than 2 doses per day. This restriction will also be put in place for the DuoResp Spiromax product. While we consider whether a product is available or not should not dictate what are clinical decisions, we intend to seek further clinical advice within the next 6 months from the Respiratory Subcommittee around the need to retain on or remove from the Schedule all high dose budesonide with formoterol products. |
Some responders highlighted there could be confusion with DuoResp Spiromax: |
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