Decision to fund a new brand of methylphenidate hydrochloride

Consumers, clinicians and professional organisations

Many responders supported the proposal noting that funding another brand of methylphenidate would:

• Help with supply and also prepare for the increase in people needing medicines from 1 Feb 2026.
• Strengthen supply resilience and reduce treatment disruptions.
• Alleviate stress for patients and whānau.
• Improve symptom control by not changing between brands frequently
• Reduce time spent by pharmacists and prescribers managing shortages

We are pleased to progress a proposal that would improve the health outcomes of New Zealanders.

Consumers

Many responders considered they were supportive as long as existing funded ADHD medicines (e.g. Concerta) are not removed.

This proposal will add a new brand of methylphenidate. We are not proposing to delist any currently funded ADHD medicines. All currently funded options would remain available for people to use and there would be no changes to the funding restrictions for these medicines. 

Supply issues

Consumers

One responder noted that supply issues are driven by worldwide demand, manufacturing limitations, and restrictions on import/exports. They considered that other methylphenidate products may experience supply challenges in the future. There was concern that funding a new brand will not resolve these wider issues and there is a risk of shortage with Sandoz too.

We acknowledge that these supply issues are affecting all methylphenidate presentations and that this is significantly impacting people.

Our contract with the supplier requires set amounts of stock to be held in New Zealand to minimise risk of a supply issue. We have been working closely with the supplier to ensure enough stock is being ordered for New Zealand.

Professional organisation

One responder considered that equitable distribution will be essential to guarantee fair access to all brands and formulations of methylphenidate, regardless of a patient’s location or the size of their local community pharmacy. Concerns were raised over pharmacies potentially stockpiling medicines.

Suppliers are responsible for ensuring stock is distributed across the country and that wholesalers are able to order sufficient quantities. Suppliers generally control release of stock to wholesalers and allocate a portion based on the market share a wholesaler has. While Pharmac does not hold formal contracts with wholesalers for these items, it relies on established working relationships to encourage responsible distribution practices. This includes requesting wholesalers to implement measures that reduce the risk of stockpiling by individual pharmacies.

Comparison to existing treatment options

Healthcare Professionals

Multiple respondents requested that detailed information about the pharmacokinetics of Methylphenidate Sandoz XR be provided to prescribers, pharmacists and the public.

Concerns were raised about this being marketed as a generic of Concerta and it not actually working in the same way. This has happened with other methylphenidate generic products.

One respondent noted that it appears that Methylphenidate Sandoz XR uses a similar osmotic release mechanism to Concerta which is why they are supportive.

Pharmac does not hold detailed pharmacokinetic information for this product. The supplier has provided the datasheet which is also available on the Medsafe website.

We have passed on this feedback to Medsafe. Medsafe is the organisation responsible for determining if a product meets the requirements to be a generic version of an already approved product.

We note there is a published bioequivalence study between Methylphenidate Sandoz XR and Concerta available online.

Bioequivalence of Sandoz XR with Concerta | National Library of Medicine(external link)

Consumer

One respondent considered that Methylphenidate Sandoz should only be funded if it is not more expensive than current medication or if it will replace one of the currently funded medicines.

The list price of Methylphenidate Sandoz XR is lower than the currently listed product Concerta. This brand will be funded as a first line treatment option.

Methylphenidate Sandoz XR will be available as an additional treatment option, it is not replacing any currently funded products.

Access to other treatment options

Consumers and clinicians

Multiple respondents highlighted the desire to have other innovative therapeutic alternatives funded for ADHD.

Some responders requested access to more non-stimulant medication e.g. long acting guanfacine and clonidine.

Any new treatments for ADHD would need to go through our normal funding application process. We have a funding application for guanfacine for ADHD(external link) and a submission for Medsafe approval was made by the supplier in November 2024. It is now awaiting advice from Pharmac’s clinical advisors.

Clinical advice on switching brands

Professional organisation

One respondent noted that methylphenidate modified release preparations are not interchangeable and must be prescribed by brand as per NZULM. Currently, switching between brands requires a new prescription. This is time consuming for patient, pharmacist, and prescriber.

We acknowledge the cost and time for people who are switching between brands of methylphenidate during this global supply shortage. We anticipate that funding an additional brand could mean there is more resilience in the supply chain and may help reduce the frequency of supply-related brand switches.

Professional organisation and clinicians

Some respondents noted that there are inconsistencies in the information published on Pharmac’s website. There is a need for Pharmac to restore and strengthen confidence in their advice by providing clear, consistent, and up-to-date guidance, along with the regulatory rules.

We are undertaking a review of the information about methylphenidate supply on our website as we have heard that it requires updating.

It is important to note that providing clinical advice is not within Pharmac’s scope; however, we are working together with Medsafe on advice for prescribers.

Impact on the sector

Professional organisation

Additional strain on pharmacies having to hold stock of three different brands leading to storage issues and greater risk of errors. Would support reducing number of funded brands to two once supply issues are resolved.

We understand that having another brand may increase the volume of stock needing to be held in pharmacies. Pharmacies also have processes to mitigate the risk of dispensing errors.

Other comments

Consumer

One respondent requested that 3-month scripts are extended to 6 months.

The length of prescriptions are determined by legislation which is outside of Pharmac’s scope. As such, we are unable to make any change to the 3-month prescriptions.

Professional organisation

One respondent noted that the proposal states that Methylphenidate Sandoz XR will have the same SA as Ritalin, Rubifen, and Methylphenidate ER – Teva. But is also described as a generic of Concerta which has different criteria for access. The inconsistency creates unnecessary administrative burden and confusion. Pharmac should standardise the approval criteria across all methylphenidate formulations.

We acknowledge the administrative burden of the Special Authority criteria for the two methylphenidate presentations.

Pharmac uses Special Authorities as a way to ensure medicines are funded for people who are most likely to benefit. This helps manage the medicines budget effectively.

For methylphenidate:

• SA2411 generally covers first-line, and/or lower-cost brands and presentations.
• SA2450 covers second-line, and/or higher-cost brands and presentations

This reflects clinical advice that most people respond well to the more cost-effective options. It also supports responsible use of funding while ensuring access to alternatives when needed.

We are working to update our website to be clearer about this for prescribers and patients.

Professional organisation

One respondent also requested that Pharmac implement integrated digital solutions that automate and streamline the application and validation of Special Authority approvals, such as a digital platform for tracking and verifying Special Authority applications that is accessible to pharmacists to quickly access and submit correct details whilst minimising communication with prescribers, and the introduction of real-time validation within prescriber PMS systems that could proactively identify and flag errors before prescriptions are sent to pharmacies.  

Pharmac does not manage the Special Authority application portal or validation of approvals. This process is managed by Health NZ.

Pharmac determines the criteria for accessing funded medicines, and the application of these restrictions is managed by Health NZ. As such, any requests to change the digital infrastructure of the Special Authority system should be raised with Health NZ. Pharmac will pass on this feedback to Health NZ.